(Study sponsor terminated study due to AE's reported with valsartan and aliskiren)

Sponsor:

Brigham and Women's Hospital

ClinicalTrials.gov Identifier:

NCT01252238

First Posted: December 2, 2010

Last Update Posted: September 5, 2013

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.

To accomplish this specific aim, we will use three approaches: a fasting HOMA Index; and a three hour glucose tolerance test. Only hypertensive subjects with insulin resistance, as assessed by HOMA index will be enrolled in the study. Insulin resistance will be assessed basally and after twelve weeks of treatment with either a calcium channel blocker with placebo, or calcium channel blocker with a renin inhibitor, or a calcium channel blocker with a renin inhibitor and an angiotensin receptor antagonist.

The same protocol and subjects will be used as defined in Specific Aim 1. Myocardial relaxation velocity (tissue Doppler imaging at the mitral annulus) and aortic compliance (characteristic aortic impedance) will be measured at baseline and then after acute and chronic renin inhibition:

Acute effect of renin inhibition: Hemodynamic measurements will be obtained on both high and low dietary sodium intake conditions (~1 week each) before and after a single dose of a renin inhibitor.

Chronic effect of renin inhibition: Hemodynamic measurements will be obtained at baseline and after 12 weeks of each of the three drug treatment arms above.

The study lasts 12 weeks and plans to study 45 hypertensive adults over the next two years.

Taking Amlodipine as prescribed by MD for management of high blood pressure.

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

18 Years to 75 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Men and women, 18-70 years old

BMI =/< 35

BP: BP > 145/95 on no BP medication or on 3 or less BP medications

HOMA =>2.5

Any race

Exclusion Criteria:

4 or more BP medications

Intolerance or known prior adverse history from taking the medications amlodipine, aliskiren or valsartan

BP >170/110 on screening exam

Alcohol intake >12 oz per week

Current smoking

Recreational drug use

Known or suspected secondary hypertension

Known history of coronary artery disease, cerebrovascular disease or congestive heart failure